Lamictal XR is an extended-release formulation of Lamictal(R)
(lamotrigine) currently in development as adjunctive therapy for patients
with partial epilepsy with or without secondary generalization. Partial
seizures, which are the most common form of epilepsy, involve a restricted
area of the brain. Secondarily generalized seizures start out affecting
only one side of the brain and evolve to affect both sides.

Results from this study, published in the October 16, 2007 edition of
Neurology demonstrated that Lamictal XR reduced partial seizures by 46
percent over the entire 19-week treatment period compared to 24 percent
with placebo. All patients enrolled in the study were inadequately
controlled on one or two antiepileptic drugs. The study also showed that 42
percent of patients treated with Lamictal XR achieved at least a 50 percent
reduction in seizure frequency compared to 24 percent of patients receiving
placebo, a reduction that was reached by some patients as early as Day 18
of the study and was sustained over the entire 19-week treatment period.

"Many patients require multiple doses of one or more medications to
control their epilepsy, which makes taking their medicines correctly and at
the right times even more challenging," said Dean Naritoku, M.D., Professor
of Neurology and Pharmacology, Southern Illinois University, Springfield,
IL. "These data are important as they show investigational Lamictal XR
taken once- daily significantly reduced seizure frequency among previously
uncontrolled patients.

About This Study

This study was an international, multi-center, randomized,
double-blind, placebo-controlled trial of patients naive to Lamictal, 13
years of age or older who were experiencing eight or more partial seizures
during the eight- week baseline period despite taking a stable regimen of
one or two antiepileptic drugs (AEDs). Two hundred and thirty-nine patients
were randomized to receive either once-daily Lamictal XR or placebo (118
Lamictal XR, 121 placebo). The 19-week treatment period of the study
consisted of a seven-week Escalation Phase and a 12-week Maintenance Phase.

The study's primary endpoint was median percent reduction from baseline
in partial seizure frequency. Study results showed that Lamictal XR
significantly reduced partial seizures by 46.1 percent, compared to 24.2
percent with placebo over the entire 19-week treatment period (P=0.0004).
The study also showed significant overall reduction in seizure frequency
with Lamictal XR in both the Escalation and Maintenance treatment phases of
the study (P=0.028 and P=0.0001, respectively).

The percentage of patients who achieved a .50 percent reduction in
partial seizure frequency during the 19-week treatment phase of the study
was also significantly higher in the Lamictal XR group compared to placebo
(42.2 percent versus 24.2 percent). In addition, the time to achieve and
maintain a .50 percent reduction in partial onset seizure frequency was
significantly shorter for the group treated with Lamictal XR compared to
placebo. Statistical significance was evident at Day 18 and was maintained
throughout the 19-week treatment phase of the study.

The median percent reduction from baseline in weekly frequency of
secondarily generalized seizures was also significantly higher in patients
receiving Lamictal XR compared to placebo (55.2 percent vs. 3.2 percent).
Similar results were observed for the escalation and maintenance phases of
the study.

The percentage of patients with at least one adverse event during the
study was 69 percent for Lamictal XR and 62 percent for placebo. The most
common adverse events in this study were headache (Lamictal XR, 17 percent
vs. placebo, 15 percent) and dizziness (Lamictal XR, 18 percent vs.
placebo, 5 percent). Non-serious rash was reported as an adverse event in
two patients receiving Lamictal XR and in one patient receiving placebo.
One of the two patients taking Lamictal XR withdrew prematurely from the
study due to non- serious rash. No serious rashes were observed in either
treatment group.

About Epilepsy

Epilepsy is defined by recurrent unprovoked seizures, or changes in
sensation, awareness, or behavior brought about by electrical disturbances
in the brain. The kind of seizure a person has depends on which part and
how much of the brain is affected by the electrical disturbance that
produces seizures. Generalized seizures are seizures that involve the
entire brain from the outset. Partial seizures, which are the most common
form of epilepsy, involve a restricted area of the brain. In approximately
70 percent of cases, the cause of epilepsy is unknown. According to the
Epilepsy Foundation, more than 3 million Americans of all ages are living
with epilepsy.

About Lamictal

Lamictal XR is an investigational therapy currently under review by the
Food and Drug Administration. The immediate-release formulation of Lamictal
is indicated 1) as adjunctive therapy for partial seizures, primary
generalized tonic-clonic seizures, and the generalized seizures of
Lennox-Gastaut syndrome in adults and pediatric patients as young as 2
years and 2) for conversion to monotherapy in adults with partial seizures
taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate as
the single AED.

Safety and effectiveness of Lamictal have not been established 1) as
initial monotherapy, 2) for conversion to monotherapy from AEDs other than
carbamazepine, phenytoin, phenobarbital, primidone, or valproate, 3) for
simultaneous conversion to monotherapy from two or more concomitant AEDs.

Lamictal is also approved for maintenance treatment of bipolar I
disorder to delay the time to occurrence of mood episodes (depression,
mania, hypomania, mixed episodes) in adult patients treated for acute mood
episodes with standard therapy. The effectiveness of Lamictal in the acute
treatment of mood episodes has not been established.

Serious rashes requiring hospitalization and discontinuation of
treatment have been reported in association with the use of Lamictal. The
incidence of these rashes, which have included Stevens-Johnson syndrome, is
approximately 0.8 percent (8 per 1000) in pediatric patients under the age
of 16 years receiving Lamictal as adjunctive therapy for epilepsy, and 0.3
percent (3 per 1000) in adults on adjunctive therapy for epilepsy. In
clinical trials of bipolar and other mood disorders, the rate of serious
rash was 0.08 percent of adult patients who received Lamictal as initial
monotherapy and 0.13 percent of adult patients who received Lamictal as
adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric
patients taking adjunctive Lamictal, there was one rash-related death.

About GlaxoSmithKline

GlaxoSmithKline (NYSE: GSK), with U.S. operations in Philadelphia, P.A.
and Research Triangle Park, N.C., is one of the world's leading
research-based pharmaceutical and healthcare companies. GlaxoSmithKline is
committed to improving the quality of human life by enabling people to do
more, feel better, and live longer. More information on GlaxoSmithKline is
available at the company's Web site at http://www.gsk.com.

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